MAUDE Adverse Event Report: CSA MEDICAL, INC. TRUFREEZE CRYOSPRAY; GEH

Model Number	CC3-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation (2001); Injury (2348)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was somewhat difficult to sedate, and he was moving around somewhat during the procedure, even prior to cryotherapy.The trufreeze device functioned normally.A rapid av catheter and cdt was used.Sedation during the procedure was midazolam 9 mg and meperidine 100 mg.Co2 insufflation was used throughout the entire procedure.No obvious kinking was noted in the tube during this procedure, and no alarms were sounded by the trufreeze device (including high pressure alert with suction).Two sites were treated with 2 x 20 second sprays.During the 4th spray, increased abdominal distension was noted by the monitor of the abdomen and treatment stopped at 15 seconds.Based on the distension seen, as well as patient tachycardia.The cryotherapy procedure was halted.The catheter and tubing were removed from the patient, and repeat egd was performed.Hyperemic tissue changes were seen at the gastroesophageal junction, but no perforation was seen.The stomach did appear collapsed, concerning for perforation.A portable abdominal radiograph after the procedure showed "impressive" pneumoperitoneum.The patient was sent to interventional radiology, where a percutaneous peritoneal drain was placed, with good decompression of the abdomen and improvement in the patient's overall condition.He was admitted to an intensive care unit, and surgical consult was obtained.They recommended observation.He was treated with iv antibiotics.Initial lactic acid was 4.4, decreased to 2.4 the next day.Baseline anemia was unchanged.Wbc rose to 11.3 but was normal the next day.Ct chest/abd/pelvis that day (after drain placement) showed minimal pneumoperitoneum.A gastrografin ugi series, followed by non-contrast abd/pelvis ct, showed no evidence of perforation.He was started on liquid diet the following day and did well.The peritoneal drain was removed on day 2 and the patient's diet was advanced to soft foods the following day.He did well and was discharged home.At home, he had transient nausea which resolved within a few days.The initial report did not reflect a serious adverse event.Following review of further details after the 30 day period, the decision was made that the event was reportable.

• Brand Name: TRUFREEZE CRYOSPRAY
• Common Device Name: GEH
• Manufacturer (Section D): CSA MEDICAL, INC.; 91 hartwell avenue; lexington MA 02421
• MDR Report Key: 8815578
• Report Number: 3010140265-2019-00002
• Device Sequence Number: 19659062
• Product Code: GEH
• UDI-Device Identifier: 00857068006099
• UDI-Public: 00857068006099
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CC3-01
• Device Catalogue Number: 20-00177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2019
• Initial Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR