The truFreeze® System is contraindicated during pregnancy; where food is identified in the stomach or proximal duodenum at the time of the procedure and cannot be removed, if used in the esophagus; where significant ulceration or mucosal break is evident in the ablation area or adjacent organs; where any procedure or pre-existing condition has significantly reduced tissue strength (e.g. Percutaneous Endoscopic Gastrostomy (PEG) tube); and where any disease state has significantly reduced the elasticity in the gastrointestinal (GI) tract or ablation area (e.g. Marfan’s Syndrome).
The truFreeze System is contraindicated where lumen narrowing exists that precludes advancing the CryoDecompression Tube (CDT) into the distal organ (e.g., stomach), if the CDT is used or where any procedure or anatomy has significantly reduced or restricted the flow area of the lumen creating a restriction where gas created from liquid nitrogen cannot adequately vent.
The most common side effects include chest pain, sore throat, difficult or painful swallowing. Other rare but serious side effects may occur. Always consult with a physician to determine whether this procedure may be appropriate for you. Physicians should consult the instructions for use for additional warnings.