CoolSculpting® Elite — Important Safety Information

Before beginning your CoolSculpting® Elite treatments, please review this important information. Results and patient experience may vary. This is not meant to cover all aspects of the CoolSculpting® Elite treatment. Please contact your healthcare provider for additional details.

CoolSculpting® Elite is a noninvasive procedure intended to break down fat cells just beneath the skin by delivering controlled cooling at the surface. It is FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen, flank, bra fat, back fat, underneath the buttocks (banana roll), and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. CoolSculpting® Elite is not a weight-loss treatment and does not replace traditional methods such as diet, exercise, or liposuction.

The CoolSculpting® Elite technology uses controlled cooling to target and freeze a portion of the fat cells under your skin. In the weeks that follow treatment, the body naturally begins to process the frozen fat cells and removes them from the treatment site, affecting the appearance of the treated bulge. You may start to see changes as early as four weeks after your procedure, with the most dramatic results between one and three months. Results can continue to evolve for up to six months and vary from person to person.

CoolSculpting® Elite is a prescription device used by or on the order of a physician. Your practitioner will discuss your treatment plan and select the appropriate applicator. Some applicators use vacuum and others do not. During treatment, a gel or gelpad and applicator are applied to the targeted area. Vacuum applicators draw tissue into the applicator cup, creating deep pulling, tugging, and mild pinching. Non-vacuum applicators may feel like pressure. Controlled cooling is delivered to the targeted fat, so you may feel intense cold, stinging, tingling, aching, cramping, or discomfort as treatment begins, but these sensations typically subside as the area becomes numb. In some cases you may feel pulsatile massage. Upon removal of the applicator, you may see a frozen bulge at the treatment area (known as a “butterstick”); your practitioner may massage the area to rewarm and smooth it.

For most patients, the procedure reduces the appearance of a visible fat bulge in the treated area.

Inform your physician of your entire medical history. CoolSculpting® Elite is not a treatment for obesity or weight loss. Do not undergo CoolSculpting® Elite if you have:

• Cryoglobulinemia: an abnormal level of cryoglobulins (proteins that thicken in cold temperatures) in the blood.
• Paroxysmal cold hemoglobinuria: a blood disorder in which a change from cold to warm temperatures leads to red blood cell death.
• Cold agglutinin disease: an autoimmune disease in which exposure of blood to cold temperatures leads to red blood cell death.

Safety/effectiveness have not been established for areas other than submental/submandibular, thigh, abdomen, flank, bra fat, back fat, under the buttocks (banana roll), and upper arm.

Not studied in children, or in people who are pregnant or lactating. Inform your provider if you have any of the following:

• Known sensitivity to cold such as cold urticaria, Raynaud’s disease, pernio, or Chilblains
• Known sensitivity or allergy to isopropyl alcohol, propylene glycol, fructose, or glycerin (use may result in allergic reactions, including anaphylaxis)
• Impaired peripheral circulation in the area to be treated
• Nerve pain such as post-herpetic neuralgia or diabetic neuropathy
• Impaired skin sensation
• Open or infected wounds
• Bleeding disorders or simultaneous use of blood thinners (may increase the risk of bleeding)
• Recent surgery or scar tissue in the area to be treated (may increase the risk of wound separation or rupture)
• Hernia in or adjacent to the treatment site
• Skin conditions such as eczema, dermatitis, or rashes in the area to be treated
• Active implanted device such as a pacemaker or defibrillator
• Chronic pain
• Anxiety disorder

Approximate worldwide estimates based on reported events per number of treatments:

• Paradoxical hyperplasia (~1/3,000; 0.033%): gradual development of enlarged tissue volume two to five months post-treatment; distinguished from temporary swelling and may require surgical intervention.
• Severe pain (~1/6,000; 0.017%): pain of varying severity, more commonly mild to moderate, though rarely severe.
• Late-onset pain (~1/6,000; 0.017%): typically starts several days after treatment and resolves within several weeks.
• Hyperpigmentation/Hypopigmentation (~1/11,000; 0.009%): dark or light skin coloration that typically resolves spontaneously.
• Freeze burn (“frostbite”) (~1/15,000; 0.006%): cold-related injury that typically resolves with proper care; second- or third-degree burns are very rare.
• Treatment Area Demarcation (TAD) (~1/20,000; 0.005%): excessive fat removal resulting in a visible disruption or indentation in the treated area.
• Vasovagal symptoms (~1/30,000; 0.003%): dizziness, lightheadedness, nausea, flushing, sweating, or fainting during or immediately after treatment.
• Subcutaneous induration (~1/30,000; 0.003%): generalized hardness and/or discrete nodules that can develop after treatment and may be accompanied by pain or discomfort.
• Cold panniculitis (~1/60,000; 0.002%): inflammatory response in adipose tissue exposed to cold; mild cases are self-resolving while severe cases may require medical or surgical intervention.
• Hernia (~1/185,000; ~0.001%): treatment may cause a new hernia or worsen a preexisting hernia, potentially requiring surgical repair.
• Headache/Occipital pain (~1/200,000; ~0.0005%): may relate to device noise or patient posture during treatment.

CoolSculpting® Elite has conducted clinical studies in the submental area, thighs, abdomen, flanks, upper arms, and with modified treatment parameters (MTP). The procedure has been studied exclusively in adult volunteers. The CoolSculpting® Elite System has not been studied in children or in people who are pregnant or lactating.

To demonstrate efficacy, independent physicians reviewed before-and-after photographs for each patient and were asked to identify the “before” image. Efficacy was also shown through ultrasound measurements that tracked fat-layer reduction after treatment.

Non-surgical options include devices using radiofrequency, ultrasound, heat, laser, or mechanical means. Surgical options include abdominoplasty and liposuction. Discuss with your physician.

Be sure to report to your physician (1) any side effect that lasts for more than two weeks and (2) any other symptom that causes you concern. You may also contact the CoolSculpting® Product Support line at 1-888-935-8471.

• www.CoolSculpting.com
• © 2025 AbbVie. COOLSCULPTING, COOLSCULPTING ELITE, and the Snowflake Design are trademarks of Zeltiq Aesthetics, Inc., an AbbVie company.
• Source: Consumer Important Safety Information (CSI), CSC146039-v4 10/25.