truFreeze 20-00180Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857068006082), received between Nov 26, 2019 and Nov 26, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS A MAN APPROXIMATELY (B)(6) WITH BARRETT'S ESOPHAGUS WITH HIGH- AND LOW-GRADE DYSPLASIA. HE WAS TREATED INITIALLY WITH RADIOFREQUENCY ABLATION BUT HAD PERSISTENT LOW-GRADE DYSPLASIA JUST BELOW THE GASTROESOPHAGEAL JUNCTION. UPPER ENDOSCOPY WITH LIQUID NITROGEN SPRAY CRYOTHERAPY WAS PERFORMED ON (B)(6) 2019. A STANDARD UPPER ENDOSCOPE WAS USED, AND CO2 INSUFFLATION WAS USED THROUGHOUT THE PROCEDURE. AFTER INITIAL ENDOSCOPY WAS PERFORMED, A WIRE WAS PASSED AND A 16 FRENCH OROGASTRIC DECOMPRESSION TUBE WAS PLACED UNEVENTFULLY AND TAPED TO THE PATIENT'S PILLOW. AN ACTIVE VENTING CATHETER WAS USED. A NURSE MONITORED THE ABDOMEN THROUGHOUT THE CRYOTHERAPY. THE CATHETER AND CONSOLE FUNCTIONED NORMALLY THROUGHOUT THE PROCEDURE, AND THE SUCTION ALARM WAS NEVER TRIGGERED. A 20 SECOND CRYOTHERAPY SPRAY WAS PERFORMED UNEVENTFULLY, AND THE TISSUE WAS ALLOWED TO THAW. AFTER 10 SECONDS OF THE SECOND SPRAY, THE PATIENT'S ABDOMEN BECAME VERY DISTENDED AND CRYOTHERAPY WAS HALTED IMMEDIATELY. THE CRYODE COMPRESSION TUBE WAS REMOVED, AND NO BENDS OR KINKS WERE NOTED. ON REPEAT EGD, THE ESOPHAGUS WAS NORMAL, HOWEVER A 2 CM PERFORATION WAS NOTED IN THE POSTERIOR GASTRIC CARDIA. ABDOMINAL D

  Patient problems: Injury; Internal Organ Perforation; Perforation

  MAUDE report 9375070 ↗