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

Model Number	CC3-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during an endoscopic procedure a patient obtained a gastric perforation while being treated for gastric antral vascular ectasia involving use of their trufreeze console.The procedure was aborted and the patient received surgery for the perforation.
Additional Manufacturer Narrative
Through follow-up with user facility personnel, it was discovered that the nurses in the room informed the physician that the cryo decompression tube was not far enough into the stomach.After the third usage of active venting spray, the patient's stomach expanded, and the procedure was aborted.The active venting spray instructions for use states, "physicians should use caution in any procedure or anatomy where a restriction or obstruction interferes with the adequate venting or nitrogen as, resulting in increased gas pressure.During cryospray, the patient must be monitored for abdominal distention and cryospray must be stopped if the abdomen becomes distended, if using in the esophagus.Liquid nitrogen expands more than 700 times when changing from a liquid to a gaseous state.It is imperative for patient safety that adequate venting is used to remove gas created during cryospray." user facility personnel were counseled on the proper use and operation of the active venting spray.No additional issues have been reported.

• Brand Name: TRUFREEZE
• Common Device Name: TRUFREEZE CONSOLE
• Manufacturer (Section D): CSA MEDICAL, INC.; 5976 heisley road; mentor 44060
• Manufacturer (Section G): CSA MEDICAL, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 21054542
• Report Number: 1528319-2025-00001
• Device Sequence Number: 20838953
• Product Code: GEH
• UDI-Device Identifier: 00857068006006
• UDI-Public: (01)00857068006006
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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: CC3-01
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 01/02/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown