CoolSculpting® Elite
System User Manual
Foreword
CS-UM-CM3-02-EN-D
11
Table 4: Rare Adverse Events
Rare Event
Description
Paradoxical hyperplasia
Visibly enlarged tissue volume within the treatment area, which may develop two
to five months after treatment. Surgical intervention may be required.
Late-onset pain
Late-onset pain may begin several days after a treatment and usually resolves
within several weeks.
Severe pain
Patients may experience pain of varying severity, which more commonly can be
described as mild to moderate, and in rare instances, can be severe.
Freeze burn
First and second-degree freeze burn may occur during treatment. It typically
resolves without sequelae with proper care.
Vasovagal symptoms
Dizziness, lightheadedness, nausea, flushing, sweating, or fainting might occur
during or immediately after the treatment.
Subcutaneous induration
Generalized hardness and/or discrete nodules within the treatment area can
develop after the treatment and might present with pain and/or discomfort.
Hyperpigmentation
Hyperpigmentation can occur after treatment and usually resolves spontaneously.
Hernia
Treatment might cause new hernia formation or exacerbate a pre-existing hernia,
which can require surgical repair.
Treatment area
demarcation
An aesthetic outcome of treatment in which the patient experiences excessive fat
removal in the treatment area, resulting in a visible disruption to the continuous
contour of fat, or unwanted indentation in the treated area.
Cold panniculitis
Cold panniculitis results from injury to adipose tissue exposed to cold and may
result in a mild to severe inflammatory response. In mild cases, the symptoms are
self-resolving and may include redness, swelling, skin nodules, warmth,
tenderness, and possible low-grade fever. These cases typically resolve without
long-term sequelae. In more severe cases, an intense inflammatory response may
result in more extensive tissue damage, including fat necrosis, which may require
medical or surgical intervention.
